Compression Sock by Textile-Based Delivery, Inc. Compression Sock

Compression Sock by

Drug Labeling and Warnings

Compression Sock by is a Otc medication manufactured, distributed, or labeled by Textile-Based Delivery, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COMPRESSION SOCK- capsaicin cloth 
Textile-Based Delivery, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Compression Sock

Active Ingredient

Synthetic Capsaicin 0.09%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache,arthritis, strains, bruises and sprains.

Warnings

For external use only

Do not use

• Allergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use
• On wounds or to damaged skin
• With, or at same time as, other analgesic products
• With a heating pad

When using this product

• You may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally diminishes.
• Do not use immediately before or after activities such as swimming, showering, or sunbathing.
• Use only as directed.
• Avoid contact with eyes and mucous membranes or rashes.
• Wash hands after putting product on body and before touching your face or eyes.

Stop use and ask a doctor if

• condition worsens, symptoms persist more than 7 days or clear up and occur again within a few days.
• rash, itching or excessive skin irritation develops.
• If pregnant or breastfeeding consult a healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean and dry affected area
• Remove product and put on body
• Maximum use of 8 hours per day
• Do not wear more than 4 days per week without doctor consent
• Wash separately for best results

Other Information

Avoid storing product in direct sunlight. Protect product from excessive moisture

Inactive Ingredients

Acrylate copolymer

Principal Display Panel

COMPRESSION SOCK 
capsaicin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72490-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.09

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72490-005-01	2 in 1 POUCH; Type 0: Not a Combination Product	04/29/2019
2	NDC: 72490-005-02	2 in 1 POUCH; Type 0: Not a Combination Product	04/29/2019
3	NDC: 72490-005-03	2 in 1 POUCH; Type 0: Not a Combination Product	04/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/29/2019	04/29/2019

Labeler - Textile-Based Delivery, Inc. (079309716)

Revised: 8/2019

Document Id: 90cda10a-d632-db5e-e053-2995a90ac8e4

34390-5

Set id: 87b129de-89f8-52b7-e053-2a95a90af9ea

Version: 2

Effective Time: 20190823

 

Textile-Based Delivery, Inc.